Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients
|ClinicalTrials.gov Identifier: NCT02202278|
Recruitment Status : Unknown
Verified July 2014 by emine seda guvendag guven, Karadeniz Technical University.
Recruitment status was: Recruiting
First Posted : July 29, 2014
Last Update Posted : July 29, 2014
|Condition or disease|
|Ovarian Hyperstimulation Syndrome|
- Patients included in this study were assisted reproductive technique (ART) patients with moderate and severe OHSS who were hospitalized for management
- Control patients are selected from patients without signs of OHSS
- All patients are administered luteal long protocol for controlled ovarian stimulation. Pituitary down-regulation with SC injection of GnRH agonist (GnRH-a) (1 mg/day; Lucrin, Abbott Laboratories, North Chicago, IL) that was started on day 21 of the previous menstrual cycle. Subcutaneous administration of recombinant hFSH (Gonal-F, Laboratories Serono S.A., Aubonne, Switzerland) at dosages from 150-225 IU/day is initiated on the second or third day of menstruation.
- When there are at least two or three follicles >17 mm in diameter, recombinant human chorionic gonadotropin (0.25 µgr ; Ovitrelle IM, Serono, Istanbul, Turkey) is applied subcutaneously 34-36 hours before oocyte retrieval.
- Serum samples are collected on day of HCG for study and control group patients.
- Serum levels of ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels.
- This is a case control study
- Statistical analyses will be performed using student t-test and fisher chi-square test. The correlations between the serums IMA, TAC, TOC, OSI, and MDA levels will be examined in all study groups using Spearman correlation analysis.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Observational Model:||Case Control|
|Official Title:||Serum Levels of IMA, TAC, TOS, OSI and MDA in Severe OHSS Patients Underwent Long Agonist Protocol Intracytoplasmic Sperm for Determining Oxidative Stress Status|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||October 2014|
ovarian hyperstimulation patients
Moderate OHSS is defined as abdominal distension and discomfort, nausea with or without vomiting, ovarian enlargement (ovarian size of 8-12 cm) and ascites that revealed by ultrasonografic examination. Severe OHSS criteria is defined as ovarian enlargement, ascites with or without hydrothorax, haematocrit >45%, weight gain >2 kg, white blood cell count >15.000, oliguria, creatinine of 1.0-1.5, creatinine clearance of >50 ml/min, liver dysfunction.
without ovarian hiperstimulation
Control group is composed of patients who underwent long luteal protocol but do not demonstrate symptoms of OHSS
- Change the levels of oxidative stress markers [ Time Frame: 1 day ]Serum will be obtained for studiying ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202278
|Contact: emine seda guvendag guven, MDemail@example.com|
|Contact: suleyman guven, MDfirstname.lastname@example.org|
|T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital||Recruiting|
|Ankara, Turkey, 06600|
|Contact: rafet duraker, MD 905342325333 email@example.com|
|Contact: yeşim bayoglu tekin, MD 05055171973 firstname.lastname@example.org|
|Sub-Investigator: Serdar Dilbaz, MD|
|Sub-Investigator: Ahmet Mentese, MD|
|Sub-Investigator: Sevim Aydin, MD|
|Study Director:||emine seda guvendag guven, MD||Karadeniz Technical University|
|Principal Investigator:||rafet duraker, MD||T. C Etlik Zubeyde Hanim Women's health Teaching Hospital|